Overview
EAM360, a next generation Mobile application for Maximo, is implemented to optimize engineering & calibration activities for GMP & GEP critical assets in a pharma manufacturing company.
Challenges:
IT system implementation is a challenge in Life sciences organizations due to compliance requirements. The transactions must have the traceability for FDA/EMA audits and systems must qualify for the IQ/OQ/PQ requirements i.e. Installation, Operational & production qualification requirements for computer system validation (CSV). The engineering team has to focus on decreasing Mean Time between Failure (MTBF) and improving wrench time while maintaining work execution records as per the stringent compliance requirements.
Some of the key challenges encountered by the team:
- Dealing with multiple calibration forms
- Managing the complex workflow processes with multiple level of approvals/reviews
- Errors in Manual calculation of results
- View the Standard Operating Procedures(SOPs), Asset history and other documents on the field.
- Capturing miscellaneous Asset events that needs to be recorded to meet the audit requirements
- View of Asset history on the fields
- Difficulties in accessing up to-date pending work order details, for the Operators and Engineers
Solution Offered:
As the leading provider of EAM mobile products, we have implemented a role-based Mobile application to support and enhance the Engineering and calibration processes for the Life sciences organization. The key solutions includes:
- View planned and unplanned work assignments with real time notifications.
- Utilization of the Maximo workflows for streamlined SOPs.
- Platform to access data & perform activities offline, in both areas with internet restrictions and remote locations with poor network coverage.
- Role based assignments for Engineering & Calibration activities.
- View Calibration asset and Loop Asset details.
- Update Calibration readings, Environment Condition, Materials, Tools, Labor, Log with photos/videos, Failure codes & Classification/Specification attributes.
- View Calibration results based on provided readings.
Solution Components:
- IBM Maximo Life sciences 7.6
- IBM Maximo Calibration 7.6.0.0
- EAM360 Technician Mobile App
Business Benefits:
Implementing an enterprise wide unified EAM solution helped the team to handle maintenance and calibration related activities effectively from a mobile device on the go. The following are a few key benefits realized by the client after using our solution:
- Fully Automated processes for executing engineering activities in the facility
- Perform tasks instantly and access Asset details from virtually anywhere even without an internet connection
- Reduction in possible human errors in data entry
- Digitisation of Calibration operations improved the calibration result calculation efficiency
- Facilitation of multiple use cases of Calibration in a single platform
- Quickly assign & reassign work orders to technician across different shifts
- Compliance with 21 CFR part 11, FDA guidelines for CSV
- The complete elimination of manual paperwork helped to achieve a greener workspace/environment
